Comparison Of Celecoxib 200 Mg Bid, Loxoprofen Sodium 60 Mg Tid And Placebo In Low Back Pain In Japan

This study has been completed.

First Received: August 30, 2005 Last Updated: September 19, 2007 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00141154

Purpose

To verify the superiority of celecoxib (YM177) 200 mg bid to placebo in treatment of patients with low back pain as well as non-inferiority to loxoprofen sodium 60 mg tid.

Condition	Intervention	Phase
Low Back Pain	Drug: Celecoxib Drug: Placebo Drug: Loxoprofen	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Multicenter, Active And Placebo Controlled Parallel Group Study To Evaluate The Efficacy And Safety Of Celecoxib (Ym177) 200 Bid Compared To Loxoprofen 60 Mg Tid In Patients With Low Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

Drug Information available for: Loxoprofen Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Patient's pain assessment (VAS: Visual Analogue Scale)

Secondary Outcome Measures:

Patient's global assessment (VAS), Physician's global assessment (VAS), Roland Morris Disability Questionnaire (RDQ)

Estimated Enrollment:	1206
Study Start Date:	October 2004

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who have the major site of the low back pain at the 12th thoracic vertebra or lower
Patients who have had low back pain for at least two weeks

Exclusion Criteria:

Patients who have a previous history or complication of rheumatoid arthritis, spondylarthrosis with negative serum reaction (ankylosing spondylarthritis, psoriatic arthritis), metastasis of tumor, Paget's disease, fibromyalgia, tumor or infection of spinal cord or intervertebral disc, or any other disease which can cause systemic pain

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141154

Show 42 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Clinical Study Results This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A3191174
Study First Received:	August 30, 2005
Last Updated:	September 19, 2007
ClinicalTrials.gov Identifier:	NCT00141154 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Celecoxib
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Low Back Pain
Enzyme Inhibitors
Pain
Back Pain
Pharmacologic Actions

Signs and Symptoms
Loxoprofen
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Neurologic Manifestations
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010